Ozanimod

Similar to fingolimod, ozanimod is thought to act by trapping certain immune cells (called T cells) in the body’s lymph nodes. This means the cells cannot enter the brain and spinal cord and therefore stops them from attacking and damaging myelin.

Ozanimod is a tablet taken daily.

RADIANCE phase 3 trial

This phase 3 trial tested if two doses of ozanimod can reduce relapses in 1,320 people with relapsing MS compared with beta interferon, over two years.

Initial results from this trial were announced in May 2017 and published in the Lancet journal in November 2019. People taking either dose of ozanimod were reported to have a lower relapse rate than those taking weekly beta interferon therapy (21% reduction for lower dose and 38% for the higher dose). Both doses also reduced the number of MRI lesions and slowed the loss of brain volume compared with beta interferon. 

SUNBEAM phase 3 trial

Results of this phase 3 trial were announced in February 2018 and published in the Lancet journal in November 2019. The trial involved 1,346 people with relapsing MS who took either a high or low dose of the drug, or beta interferon, for one year.

Both doses of ozanimod significantly reduced relapse rates compared with beta interferon (48% for the high dose and 28% for the low dose). Ozanimod also reduced the number of new lesions on MRI scans by 66% (high dose) and 25% (low dose) compared with beta interferon.

Extension study

Celgene are also running an extension study. This means that every participant on the phase 3 trials can continue taking ozanimod after those trials finish for up to five years. This will be to evaluate any long-term adverse effects, and is due to finish in 2020. In 2019 the team announced that the extension study had not revealed any new safety concerns so far. The full results are not yet available. 

Earlier research

258 people with relapsing MS either took either a high of low dose of ozanimod or a placebo for 24 weeks.

Ozanimod significantly reduced the number of MRI lesions compared to placebo. 

In the phase 2 trial, three serious adverse effects (optic neuritis, unexplained pain and cellular changes to the cervix) were noted, but not proven to be related to the therapy.

Other reactions included colds, headaches and urinary tract infections. Some people had an initial increased heart rate, but this could be managed by gradually increasing the dose given. Ozanimod caused temporary increases in liver enzymes which generally returned to normal levels without the need to stop treatment.

The SUNBEAM and RADIANCE trials compared ozanimod to beta interferon-1a (an available disease modifying therapy). They found that ozanimod significantly reduced relapse rates and the number of MRI lesions and slowed the loss of brain volume, compared with beta interferon.

Researchers have also indirectly compared ozanimod with fingolimod by looking at the results of separate trials. The two drugs reduced relapse rates and disability progression to a similar extent. Ozanimod was associated with lower risks of side effects compared with fingolimod. However, no head-to-head trials have compared ozanimod and fingolimod.

Celgene presented data from the phase 3 trials to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). 

In 2020 the FDA approved ozanimod capsules for the treatment of adults with relapsing MS, clinically isolated syndrome, and active secondary progressive MS.

Ozanimod also received a positive opinion recommending approval in the EU for the treatment of adults with relapsing MS who were experiencing relapses or new lesions on MRI scans.